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1.Remove high-density polyethylene tube holder and foam insert from polycarbonate unit. Discard foam insert. 2.Add 100% isopropyl alcohol to the fill line on the Mr. Frosty container. DO NOT overfill. 3.

Trazimera package insert

10 Produkt Trazimera jest przeznaczony do podawania dożylnego. Dawka nasycająca powinna być podawana w 90-minutowym wlewie dożylnym. Nie podawać przez wstrzyknięcie ani jako bolus. Wlew dożylny produktu Trazimera powinien być prowadzony przez wykwalifikowany personel The mean values printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control. 2. Herzuma [package insert].

Trazimera® 420 mg powder for concentrate for solution for infusion. t.

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Whitehouse Station, NJ: Merck Sharp and Dohme Corp.; March 2020. 6. Trazimera [package insert].

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Ontruzant [package insert].

Do not freeze. Dilution. Determine the dose (mg) of TRAZIMERA [see Recommended Doses and Schedules]. Summary: Trazimera is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Pfizer. Originally designated PF-05280014 , a biologic license application for approval via the 351(k) biosimilar pathway was initially submitted to the Food and Drug Administration (FDA) in the third quarter of 2017. Trazimera’s data package that led to approval included findings from the comparative clinical trial for the biosimilar, REFLECTIONS B327-02.
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For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in • Package Insert For Information Only - Not A Controlled Copy. Xpert® MTB/RIF 4 Xpert® MTB/RIF 301-1404, Rev. F August 2019 6.2 Storage and Handling • Store the Xpert MTB/RIF Assay cartridges and reagents at 2 – 28 °C. • Do not use reagents or cartridges that have passed the expiration date. •Administer TRAZIMERA, alone or in combination with paclitaxel, at an initial dose of 4 mg/kg as a 90-minute intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30-minute 2019-06-03 · Trazimera 420 mg multiple-dose vial; lyophilized powder for injection: 00069-0305-xx VII. References 1.

Lyman GH, Balaban E, Diaz M, et al: See Full Prescribing Information for complete risk information. Chronic Kidney Herceptin KANJINTI* Ogivri* Trazimera* HERZUMA*. Figure 8.
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8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date as part of the REFLECTIONS studies. 5,6,7,12,13 TRAZIMERA safety information Do not use TRAZIMERA if you are allergic to trastuzumab or any of its ingredients, if you have severe breathing problems at rest due to your cancer or if you need oxygen treatment. Find patient medical information for Trazimera intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.

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Cork, Ireland; Pfizer Ireland, Inc; March 2019. Accessed November 2019. 2. Referenced with permission from the NCCN Drugs & Biologics TRAZIMERA • Advise pregnant women and females of reproductive potential that exposure to TRAZIMERA during pregnancy or within 7 months prior to conception can result in fetal harm • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of TRAZIMERA Package Leaflet: Information for the user.

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What is Ogivri? ADJUVANT BREAST CANCER .

TRAZIMERA™ (trastuzumab-qyyp) - See Boxed Warning www.pfizerpro.com. View TRAZIMERA™ Prescribing Info, Safety Info And Boxed Warning. Find Patient Dosing Info. TRAZIMERA™ Patient Site Prescribing Information Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal 2020-08-17 2020-12-09 March 11, 2019 – Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an Trastuzumab injection is used to treat HER2-overexpressing new or metastatic (cancer that has spread) breast cancer.It can be used alone or with other cancer medicines (eg, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel). Trastuzumab injection is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that Click on the carboplatin (Paraplatin) package insert below for reported side effects and possible drug interactions; Side Effect Videos Nausea and Vomiting Diarrhea Hair Loss Bleeding Constipation Pain Anemia See DailyMed package insert.